relapsing vulvar carcinoma already subjected to multiple treatments MedDRA version: 21.1 Level: LLT Classification code 10026642 Term: Malignant neoplasm of vulva recurrent System Organ Class: 100000004864
Conditions
Interventions
Trade Name: BLEOPRIM - 15 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
Product Name: bleomicina
Product Code: [bleomicina]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Prop
Sponsors
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old 2. Recurrent vulvar carcinoma confirmed by histological examination (sec. WHO 2020) 3. Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), alternatively patient not eligible for standard therapies due to the performance 4. Status life expectancy more than three months 5. Measurable disease according to RECIST 1.1 6. Adequate bone marrow, liver, and kidney function (creatinine 1,5 - Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) =3.0 × upper limit of normal (ULN) - Total bilirubin =2.0 × ULN or =3 × ULN except for subjects with Gilbert’s syndrome - Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. History of other malignancies in the previous five years, except basal cell carcinoma of the skin. 2. History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule. 3. Allergic reactions to the two chemotherapy drugs (BLM and CBP) and/or their excipients. 4. Evidence of pulmonary fibrosis. 5. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification =II [NYHA 1994]), myocardial infarction within 6 months of study entry. 6. Patients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded). 7. Pregnant or breastfeeding. 8. Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Evaluate the oncology response to electroporation after administration of BLM + CBP to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.;Secondary Objective: •Compare quality of life (HR-QoL) in the two groups of patients with questionnaires (FACT-V, FACT-PAL, E5-5L-D5). •To compare Overall Survival in the two study arms. •To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms. •To compare costs and cost-effectiveness between the two study arms.;Primary end point(s): local progression free survival;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
Italy
Contacts
Public ContactSSD Oncologia Ginecologica - De Iac
AOU di Bologna Policlinico S.Orsola
Outcome results
None listed